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Trial record 1 of 15 for:    Ad26.Filo
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A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02860650
First received: August 4, 2016
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.

Condition Intervention Phase
Healthy Biological: Ad26.Filo Biological: MVA-BN-Filo Biological: Ad26.ZEBOV Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult

Further study details as provided by Janssen Vaccines & Prevention B.V.:

Primary Outcome Measures:
  • Number of Participants With Adverse events (AEs) [ Time Frame: Up to 28 days after the last vaccination ]
  • Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) [ Time Frame: One Week after each study vaccine administration ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to the end of long-term follow-up (Day 360) ]

Secondary Outcome Measures:
  • Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs) [ Time Frame: Up to Day 360 ]

Enrollment: 72
Actual Study Start Date: August 29, 2016
Estimated Study Completion Date: September 21, 2017
Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: AD26.Filo/MVA-BN-Filo or Placebo
Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
Biological: Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
Biological: MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
Biological: Placebo
IM injection of 0.9 percent saline.
Experimental: Group 2: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.
Biological: Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
Biological: MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
Biological: Placebo
IM injection of 0.9 percent saline.
Experimental: Group 3: MVA-BN-Filo/AD26.Filo or Placebo
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.
Biological: Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
Biological: MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
Biological: Placebo
IM injection of 0.9 percent saline.
Experimental: Subset of Group 3: AD26.Filo or Placebo
The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination.
Biological: Ad26.Filo
Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
Biological: Placebo
IM injection of 0.9 percent saline.
Experimental: Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.
Biological: Ad26.ZEBOV
Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.
Biological: Placebo
IM injection of 0.9 percent saline.
Biological: MVA-BN-Filo
MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) of greater than or equal to (>=) 18.5 and less than (<) 35.0 kilogram per square meter (kg/m^2)
  • Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
  • All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination
  • Participant must be available and willing to participate for the duration of the study visits and follow-up

Exclusion Criteria:

  • Has been vaccinated with a candidate filovirus vaccine
  • Has received any Ad26- or MVA-based candidate vaccines in the past
  • Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study
  • Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
  • Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (>=) 38.0 degree Celsius on Day 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02860650

Locations
United States, Maryland
Rockville, Maryland, United States
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
  More Information

Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02860650     History of Changes
Other Study ID Numbers: CR108144
VAC69120FLV1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Study First Received: August 4, 2016
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017